Delivery system having retractable wires as a coupling mechanism and a deployment mechanism for a self-expanding prosthesis

ABSTRACT

A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.

FIELD OF THE INVENTION

The invention is related in general to a delivery system for aself-expanding prosthesis, and more particularly to a delivery systemthat utilizes retractable flat wires as a coupling mechanism and adeployment mechanism for a self-expanding prosthesis.

BACKGROUND OF THE INVENTION

A human heart includes four heart valves that determine the pathway ofblood flow through the heart: the mitral valve, the tricuspid valve, theaortic valve, and the pulmonary valve. The mitral and tricuspid valvesare atrioventricular valves, which are between the atria and theventricles, while the aortic and pulmonary valves are semilunar valves,which are in the arteries leaving the heart. Ideally, native leaflets ofa heart valve move apart from each other when the valve is in an openposition, and meet or “coapt” when the valve is in a closed position.Problems that may develop with valves include stenosis, in which a valvedoes not open properly, and/or insufficiency or regurgitation in which avalve does not close properly. Stenosis and insufficiency may occurconcomitantly in the same valve. The effects of valvular dysfunctionvary, with regurgitation or backflow typically having relatively severephysiological consequences to the patient.

Recently, flexible prosthetic valves supported by stent or scaffoldstructures that can be delivered percutaneously using a catheter-baseddelivery system have been developed for heart and venous valvereplacement. These prosthetic valves may include either self-expandingor balloon-expandable stent structures with valve leaflets attached tothe interior of the stent structure. The prosthetic valve can be reducedin diameter, by compressing onto a balloon catheter or by beingcontained within an outer sheath component of a delivery catheter, andadvanced through the venous or arterial vasculature. Once the prostheticvalve is positioned at the treatment site, for instance within anincompetent native valve, the stent structure may be expanded to holdthe prosthetic valve firmly in place. One example of a stentedprosthetic valve is disclosed in U.S. Pat. No. 5,957,949 to Leonhardt etal. entitled “Percutaneous Placement Valve Stent”, which is incorporatedby reference herein in its entirety. Another example of a stentedprosthetic valve for a percutaneous pulmonary valve replacementprocedure is described in U.S. Patent Application Publication No.2003/0199971 A1and U.S. Pat. No. 8,721,713, both filed by Tower et al.,each of which is incorporated by reference herein in its entirety.

Although transcatheter delivery methods have provided safer and lessinvasive methods for replacing a defective native heart valve,complications may arise including vessel trauma due to percutaneousdelivery within highly curved anatomy and/or due to a large deliveryprofile of the prosthesis, inaccurate placement of the valve prosthesis,conduction disturbances, coronary artery obstruction, and/or undesirableparavalvular leakage and/or regurgitation at the implantation site.Embodiments hereof are directed to a valve prosthesis system having animproved configuration to address one or more of the afore-mentionedcomplications.

BRIEF SUMMARY OF THE INVENTION

Embodiments hereof relate to a delivery system for transcatheterimplantation of a heart valve prosthesis. The delivery system includesan outer sheath component defining a lumen therethrough, an elongatetube having at least two wires longitudinally extending from a distalend thereof, and self-expanding first and second frames disposed inseries within a distal portion of the outer sheath component and held ina compressed delivery configuration therein. The elongate tube and theat least two wires being slidably disposed within the lumen of the outersheath component. In the compressed delivery configuration the at leasttwo wires longitudinally extend along exterior portions of the first andsecond frames and are woven through adjacent ends of the first andsecond frames to releasably couple them to each other.

In another embodiment hereof, a delivery system for transcatheterimplantation of a heart valve prosthesis includes an outer sheathcomponent defining a lumen therethrough, an elongate tube defining alumen and having at least two wires longitudinally extending from adistal end thereof, a valve prosthesis having a self-expanding valveframe with a prosthetic valve component secured therein, and aself-expanding docking frame. The elongate tube and the at least twowires being slidably disposed within the lumen of the outer sheathcomponent. The docking frame is disposed distal of the valve prosthesiswhen each is held in a compressed delivery configuration within a distalportion of the outer sheath component. In the compressed deliveryconfiguration the at least two wires longitudinally extend alongexterior portions of the valve frame and the docking frame and are woventhrough adjacent distal and proximal ends of the valve frame and thedocking frame, respectively, to releasably couple them to each other.

Embodiments hereof also relate to a method of implanting a valveprosthesis within a native valve. A delivery system is percutaneouslyadvanced to the native valve. The delivery system includes an outersheath component defining a lumen therethrough, an elongate tubedefining a lumen and having at least two wires longitudinally extendingfrom a distal end thereof, and the elongate tube and the at least twowires being slidably disposed within the lumen of the outer sheathcomponent. The delivery system further includes a valve prosthesishaving a self-expanding valve frame with a prosthetic valve componentsecured therein and a self-expanding docking frame, the docking framebeing disposed distal of the valve prosthesis and each frame being heldin a compressed delivery configuration within a distal portion of theouter sheath component. The at least two wires longitudinally extendalong exterior portions of the valve frame and the docking frame and arewoven through adjacent distal and proximal ends of the valve frame andthe docking frame, respectively, to releasably couple them to eachother. The outer sheath component is proximally retracted to uncover thedocking frame and thereby deploy the docking frame to an expandedconfiguration within the native valve. The outer sheath component isfurther proximally retracted to uncover the valve frame and therebydeploy the valve frame to an expanded configuration. The at least twowires is proximally retracted from the deployed docking frame touncouple the deployed docking frame from the deployed valve frame. Thedeployed valve frame is recaptured into the outer sheath component. Therecaptured valve frame is repositioned within the deployed dockingframe. The outer sheath component is proximally retracted to uncover therecaptured valve frame and thereby deploy the valve frame to an expandedconfiguration within the deployed docking frame.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following description of embodiments hereof asillustrated in the accompanying drawings. The accompanying drawings,which are incorporated herein and form a part of the specification,further serve to explain the principles of the invention and to enable aperson skilled in the pertinent art to make and use the invention. Thedrawings are not to scale.

FIG. 1 is a side view of a delivery system according to an embodimenthereof, wherein an outer sheath of the delivery system is in anon-retracted, delivery configuration and is disposed or extends overfirst and second frames such that the first and second frames are heldin a compressed delivery configuration therein.

FIG. 1A is a cross-sectional view taken along line A-A of FIG. 1.

FIG. 2 is a perspective view of the first frame of FIG. 1, wherein thefirst frame is removed from the delivery system for sake of illustrationonly.

FIG. 3 is a perspective view of the second frame of FIG. 1, wherein thesecond frame is removed from the delivery system for sake ofillustration only.

FIG. 4 is a side view of a distal portion of an elongate tube of thedelivery system of FIG. 1, wherein the elongate tube includes at leasttwo flat wires longitudinally extending from a distal end thereof andthe elongate tube is removed from the delivery system for sake ofillustration only.

FIG. 5 is a side sectional view of a distal portion of FIG. 1.

FIG. 6 is a perspective view of the first and second frames and a flatwire of FIG. 1, the first and second frames being shown in theirdeployed configurations and being shown removed from the delivery systemfor sake of illustration only, wherein the flat wire is woven through acircumferential overlap region of the first and second frames toreleasably couple the frames together.

FIG. 7 is a side view of the delivery system of FIG. 1, wherein theouter sheath of the delivery system is in retracted configuration, thefirst and second frames are in their expanded or deployedconfigurations, and the flat wires are shown radially extending beyondthe first and second frames for illustrative purposes only.

FIG. 8 illustrates a step for deploying the first and second frames anddecoupling at least the first or distal frame from the delivery systemof FIG. 1, wherein the step includes retraction of the outer sheath ofthe delivery system.

FIG. 9 illustrates a step for deploying the first and second frames anddecoupling at least the first or distal frame from the delivery systemof FIG. 1, wherein the step includes further retraction of the outersheath of the delivery system to expose or uncover the first frame.

FIG. 10 illustrates a step for deploying the first and second frames anddecoupling at least the first or distal frame from the delivery systemof FIG. 1, wherein the step includes further retraction of the outersheath of the delivery system to also expose or uncover the secondframe.

FIG. 11 illustrates a step for deploying the first and second frames anddecoupling at least the first or distal frame from the delivery systemof FIG. 1, wherein the step includes retraction of the flat wires todecouple the first frame from the second frame.

FIG. 12 illustrates a step for deploying the first and second frames anddecoupling at least the first or distal frame from the delivery systemof FIG. 1, wherein the step includes retraction of second frame toseparate the second frame from the first frame.

FIG. 13 illustrates a step for deploying the first and second frames anddecoupling at least the first or distal frame from the delivery systemof FIG. 1, wherein the step includes retraction of second frame into theouter sheath for recapture.

FIG. 14 illustrates a step for deploying the first and second frames anddecoupling at least the first or distal frame from the delivery systemof FIG. 1, wherein the step includes further retraction of second frameinto the outer sheath for recapture.

FIG. 15 is a side view of a distal portion of an inner shaft of thedelivery system of FIG. 1 according to an embodiment hereof, wherein asecond or delivery frame is permanently attached or secured to a distalend of the inner shaft to be slidable therewith.

FIG. 16 is a side view of a valve prosthesis to be used with thedelivery frame of FIG. 15, the valve prosthesis being shown in itsexpanded configuration and being removed from the delivery system forillustrative purposes only, wherein the valve prosthesis includes afirst or valve frame and a prosthetic valve component disposed therein.

FIG. 17 is an end view of the valve prosthesis of FIG. 16.

FIG. 18 is a perspective view of a valve frame according to anotherembodiment hereof.

FIG. 19 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes delivery of the delivery system with theouter sheath thereof in a non-retracted, delivery configuration suchthat the valve and delivery frames are held in a compressed deliveryconfiguration therein.

FIG. 20 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes proximal retraction of the outer sheath toexpand or deploy the valve and delivery frames.

FIG. 21 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes proximal retraction of the flat wires todecouple the valve and delivery frames.

FIG. 22 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes proximal retraction of the delivery frameto separate the delivery frame from the valve frame.

FIG. 23 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes proximal retraction of the delivery frameinto the outer sheath to recapture the delivery frame for removalthereof

FIG. 24 is a side view of a distal portion of an inner shaft of thedelivery system of FIG. 1 according to an embodiment hereof, wherein avalve prosthesis is releasably secured to a distal end of the innershaft to be slidable therewith, and the valve prosthesis includes afirst or valve frame and a prosthetic valve component disposed therein.

FIG. 25 is a perspective view of the releasable connection between thevalve prosthesis and the inner shaft.

FIG. 26 is a side view of a docking frame to be used with the valveframe of FIG. 24, the docking frame being shown in its expandedconfiguration and being removed from the delivery system forillustrative purposes only.

FIG. 27 illustrates a step for implanting the valve prosthesis of FIG.24, wherein the step includes delivery of the delivery system with theouter sheath thereof in a non-retracted, delivery configuration suchthat the docking and valve frames are held in a compressed deliveryconfiguration therein.

FIG. 28 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes proximal retraction of the outer sheath toexpand or deploy the docking and valve frames.

FIG. 29 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes proximal retraction of the flat wires todecouple the docking and valve frames.

FIG. 30 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes proximal retraction of the valve frame toseparate the valve frame from the docking frame.

FIG. 31 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes proximal retraction of the valve frameinto the outer sheath to recapture the valve frame.

FIG. 32 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes distal advancement of the outer sheath andvalve frame compressed therein to position the valve frame within thedeployed docking frame.

FIG. 33 illustrates a step for implanting the valve prosthesis of FIG.16, wherein the step includes proximal retraction of the outer sheath toexpand and deploy the valve frame within the deployed docking frame.

DETAILED DESCRIPTION OF THE INVENTION

Specific embodiments of the present invention are now described withreference to the figures, wherein like reference numbers indicateidentical or functionally similar elements. Specific embodiments are nowdescribed with reference to the figures, wherein like reference numbersindicate identical or functionally similar elements. Unless otherwiseindicated, the terms “distal” and “proximal” are used in the followingdescription with respect to a position or direction relative to thetreating clinician. “Distal” and “distally” are positions distant fromor in a direction away from the clinician, and “proximal” and“proximally” are positions near or in a direction toward the clinician.In addition, the term “self-expanding” is used in the followingdescription with reference to one or more stent structures of theprostheses hereof and is intended to convey that the structures areshaped or formed from a material that can be provided with a mechanicalmemory to return the structure from a compressed or constricted deliveryconfiguration to an expanded deployed configuration. Non-exhaustiveexemplary self-expanding materials include stainless steel, apseudo-elastic metal such as a nickel titanium alloy or nitinol, variouspolymers, or a so-called super alloy, which may have a base metal ofnickel, cobalt, chromium, or other metal. Mechanical memory may beimparted to a wire or stent structure by thermal treatment to achieve aspring temper in stainless steel, for example, or to set a shape memoryin a susceptible metal alloy, such as nitinol. Various polymers that canbe made to have shape memory characteristics may also be suitable foruse in embodiments hereof to include polymers such as polynorborene,trans-polyisoprene, styrene-butadiene, and polyurethane. As well polyL-D lactic copolymer, oligo caprylactone copolymer and poly cyclo-octinecan be used separately or in conjunction with other shape memorypolymers.

The following detailed description is merely exemplary in nature and isnot intended to limit the invention or the application and uses of theinvention. Although the description of the invention is in the contextof replacement of aortic valves, the prosthetic valves of the inventioncan also be used in other areas of the body, such as for replacement ofa native mitral valve, for replacement of a native pulmonic valve, forreplacement of a native tricuspid valve, for use as a venous valve, orfor replacement of a failed previously-implanted prosthesis.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

Embodiments hereof relate to a delivery system for a valve prosthesisthat utilizes flexible flat wires as both a coupling mechanism and adeployment mechanism. More particularly, the delivery system includes anouter sheath component defining a lumen therethrough, an elongate tubehaving at least two flat wires longitudinally extending from a distalend thereof, and self-expanding first and second frames disposed inseries within a distal portion of the outer sheath component and held ina compressed delivery configuration therein. As will be explained inmore detail herein, a prosthetic valve component may be disposed in thefirst frame or in the second frame. The elongate tube is slidablydisposed within the lumen of the outer sheath component. In thecompressed delivery configuration, in which the first and second framesare disposed in series within a distal portion of the outer sheathcomponent, the two flat wires longitudinally extend along exteriorportions of the first and second frames and are woven through adjacentends of the first and second frames to releasably couple them to eachother. Proximal retraction of the flat wires from the first and secondframes releases at least the first frame from the delivery system suchthat the flat wires serve as a coupling mechanism for the deliverysystem. In addition, when the outer sheath component is proximallyretracted to uncover the first and second frames for deployment thereof,the flat wires slow the self-expansion of frames to control deploymentof the valve prosthesis such that the flat wires also serve as adeployment mechanism for the delivery system.

More particularly, with reference to the side view of FIG. 1 and thecross-sectional view of FIG. 1A taken along line A-A of FIG. 1, deliverysystem 100 includes an outer sheath component or cover 106, an elongatetube 136 slidingly disposed within outer sheath component 106, and aninner shaft 116 slidingly disposed within elongate tube 136. Elongatetube 136 has at least two flat or ribbon wires 146 longitudinallyextending from a distal end 142 thereof which are utilized as both acoupling mechanism and a deployment mechanism for delivery system 100.Self-expanding first and second frames 102, 104, respectively, aredisposed or mounted at a distal portion of delivery system 100. Firstand second frames 102, 104 are disposed in series such that they areadjacent to each other or side-by-side in a longitudinal direction,i.e., along a longitudinal axis L_(A) of delivery system 100. Firstframe 102 is disposed distal to second frame 104, and thus first frame102 may be referred to herein as distal frame 102 and second frame 104may be referred to herein as proximal frame 104.

As shown in the perspective views of FIGS. 2 and 3, first and secondframes 102, 104 are shown in their expanded or deployed configurationsand removed from delivery system 100 for illustrative purposes only.First and second frames 102, 104 each include a self-expanding scaffold154, 164, respectively, that returns to an expanded deployed state froma compressed or constricted delivery state. In this embodiment,self-expanding scaffolds 154, 164 are tubular components having proximalends or segments 158, 168, respectively, and distal ends or segments160, 170, respectively, with diamond-shaped openings 156, 166,respectively, that may be formed by a laser-cut manufacturing methodand/or another conventional stent/scaffold forming method as would beunderstood by one of ordinary skill in the art. However, it will beunderstood by one of ordinary skill in the art that the illustratedconfigurations of first and second frames 102, 104 are exemplary andself-expanding scaffolds 154, 164 may have alternative patterns orconfigurations. For example, in another embodiment (not shown),self-expanding scaffolds 154, 164 may include one or more sinusoidalpatterned rings coupled to each other to form a tubular component.Further, depending upon application thereof and as will be described inmore detail herein, the first and/or second frame may each have distinctconfigurations and/or include an additional element that aids in fixingor anchoring the self-expanding frame within native valve anatomy.

With reference to FIG. 1 and FIG. 1A, the main components of deliverysystem 100 will now be described in more detail. Outer sheath component106 is an elongate shaft or tubular component that defines a lumen 108extending from a proximal end 110 to a distal end 112 thereof. Outersheath component 106 is movable in an axial direction along and relativeto inner shaft 116 and extends to a proximal portion of the deliverysystem where it may be controlled via an actuator, such as a handle 114to selectively expand first and second frames 102, 104. Handle 114 maybe a push-pull actuator that is attached or connected to proximal end110 of outer sheath component 106. Alternatively, the actuator may be arotatable knob (not shown) that is attached or connected to proximal end110 of outer sheath component 106 such that when the knob is rotated,outer sheath component 106 is retracted in a proximal direction toexpand the first and second frames. Alternatively, the actuator may usea combination of rotation and sliding to retract outer sheath component106, as described, for example, in U.S. Pat. No. 7,419,501 to Shiu etal., U.S. Patent Publication No. 2011/0257718 to Argentine, U.S. PatentPublication No. 2011/0270371 to Argentine, and U.S. Patent PublicationNo. 2011/0270372 to Argentine, each of which is incorporated byreference herein. Thus, when the actuator is operated, i.e., manuallyturned or pulled, outer sheath component 106 is proximally retractedover inner shaft 116 in a proximal direction. Outer sheath component 106may be constructed of any suitable flexible polymeric material,including but not limited to polyethylene terephalate (PET), nylon,polyethylene, PEBAX, or combinations thereof, either blended orco-extruded.

Elongate tube 136 having flat wires 146 longitudinally extending fromdistal end 142 thereof is an elongate shaft or tubular component thatdefines a lumen 138 extending from a proximal end 140 to distal end 142thereof. Elongate tube 136 is slidingly disposed within lumen 108 ofouter sheath component 106. Elongate tube 136 is movable in an axialdirection along and relative to inner shaft 116 and extends to aproximal portion of the delivery system where it may be controlled viaan actuator, such as a handle 144 to selectively proximally retract flatwires 146. Handle 144 may be a push-pull actuator, a rotatable knob, oran actuator that uses a combination of rotation and sliding to retractthe shaft component as described herein with respect to handle 114 andis attached or connected to proximal end 140 of elongate tube 136.Elongate tube 136 may be constructed of any suitable flexible polymericmaterial, including but not limited to polyethylene terephalate (PET),nylon, polyethylene, PEBAX, or combinations thereof, either blended orco-extruded. A side view of a distal portion of elongate tube 136 isshown in FIG. 4. Elongate tube 136 includes a total of three flat wires146A, 146B, 146C, collectively referred to herein as flat wires 146,which longitudinally extend from distal end 42 of elongate tube 136.More particularly, proximal ends 148 of each flat wire 146 is attachedor fixed to distal end 142 of elongate tube 136 and distal ends 150 arenot attached or free ends such that flat wires 146 may be woven throughfirst and second frames 102, 104 to couple them to the delivery systemas will be explained in more detail herein. Although shown with threeflat wires 146, it will be understood by those of ordinary skill in theart that a greater or smaller number of flat wires may be used dependingupon the size or diameter of first and second frames 102, 104. Further,although flat wires 146 preferably having an oval, oblong, orrectangular cross-section and a flat or flattened profile in order tominimize the delivery profile thereof, the wires may alternatively havea circular or other shape cross-section as will be understood by thoseof ordinary skill in the art. The length of flat wires 146 depend uponthe length of first and second frames 102, 104 as flat wires 146 areconfigured to extend at least approximately the full length of the firstand second frames 102, 104 when in the compressed deliveryconfiguration. Flat wires 146 may be formed from Nitinol, stainlesssteel, PEEK, or similar materials.

Inner shaft 116 is an elongate shaft or tubular component that defines alumen 118 extending from a proximal end 120 to a distal end 122 thereof.Lumen 118 of inner shaft 116 is sized to slidingly receive a plunger(shown in FIG. 19) with a dilator tip (shown in FIG. 19) at a distal endthereof. The plunger defines a guidewire lumen such that delivery system100, including the plunger extending therethrough, may be advanced overa guidewire (shown in FIG. 19) to assist in tracking the delivery systemto the target site within the vasculature. Inner shaft 116 is slidinglydisposed within lumen 138 of elongate tube 136. As will be described inmore detail herein, distal end 122 of inner shaft 116 is coupled toproximal end 168 of second or proximal frame 104. In an embodimenthereof, distal end 122 of inner shaft 116 is permanently attached to theproximal end of second or proximal frame 104 such that proximal frame104 is a permanent component of the delivery system. In anotherembodiment hereof, distal end 122 of inner shaft 116 is releasablycoupled to the proximal end of second or proximal frame 104 such thatproximal frame 104 may be selectively detached from the delivery systemand thus is not a permanent component of the delivery system. Innershaft 116 is movable in an axial direction along and relative to outersheath component 106 and extends to a proximal portion of the deliverysystem where it may be controlled via an actuator, such as a handle 124to selectively proximally retract second or proximal frame 104. Handle124 may be a push-pull actuator, a rotatable knob, or an actuator thatuses a combination of rotation and sliding to retract the shaftcomponent as described herein with respect to handle 114 and is attachedor connected to proximal end 120 of inner shaft 116. Inner shaft 116 maybe constructed of any suitable flexible polymeric material, includingbut not limited to polyethylene terephalate (PET), nylon, polyethylene,PEBAX, or combinations thereof, either blended or co-extruded.

In order to couple first and second frames 102, 104 to delivery system100, distal end 122 of inner shaft 116 is coupled to proximal end 168 ofsecond or proximal frame 104 as stated above and second or proximalframe 104 is releasably coupled to proximal end 158 of first or distalframe 102. In the compressed delivery configuration of FIG. 1, outersheath component 106 is in a non-retracted, delivery configuration andis disposed or extends over first and second frames 102, 104 such thatthe first and second frames are held or retained in a compresseddelivery configuration therein. As best shown in the sectional view ofFIG. 5, when in the compressed delivery configuration, first and secondframes 102, 104 are mounted in series with proximal end 158 of first ordistal frame 102 overlapping distal end 170 of second or proximal frame104 to provide a circumferential overlap region 162 therebetween. Moreparticularly, distal end or segment 170 of second or proximal frame 104is disposed or nested within proximal end or segment 158 of first ordistal frame 102 such that proximal end 158 of first or distal frame 102overlays or covers distal end 170 of second or proximal frame 104 atcircumferential overlap region 162. However, as will be understood bythose of ordinary skill in the art, proximal end 158 of first or distalframe 102 may alternatively be disposed within distal end 170 of secondor proximal frame 104 at circumferential overlap region 162.

With additional reference to the enlarged view of FIG. 6, flat wires 146are woven through overlapping openings 156, 166 of first and secondframes 102, 104 along circumferential overlap region 162 in order toreleasably couple first and second frames 102, 104 together. Theenlarged view of FIG. 6 illustrates only a single flat wire 146 forclarity. In the circumferential overlap region 162, each flat wire 146is threaded under or woven through a respective distalmost crown 155 ofsecond or proximal frame 104. More particularly, flat wire 146 extendsalong an outer surface of second or proximal frame 104. Distal toproximal end 158 of first or distal frame 102 and within circumferentialoverlap region 162, flat wire 146 passes through a first set 161 ofoverlapping openings 156, 166 within circumferential overlap region 162such that flat wire 146 is disposed within first or distal frame 102.Proximal to distal end 170 of second or proximal frame 104 and withincircumferential overlap region 162, flat wire 146 passes through asecond set 163 of overlapping openings 156, 166 within circumferentialoverlap region 162 such that flat wire 146 is disposed and extends alongan outer surface of first or distal frame 102 for the remaining lengththereof. As a result, once all flat wires 146 are positioned in asimilar manner, first or distal frame 102 is releasably coupled tosecond or proximal frame 104 as well as to delivery system 100 (viasecond or proximal frame) via flat wires 146.

As shown in FIG. 7, proximal retraction of flat wires 146 fromcircumferential overlap region 162 releases at least first or distalframe 102 from delivery system 100. When flat wires 146 are proximallyretracted such that they are no longer woven through overlappingopenings 156, 166 of first and second frames 102, 104 alongcircumferential overlap region 162, first and second frames 102, 104 areno longer coupled together via the flat wires. Second or proximal frame104 (which is coupled to inner shaft 116) may be proximally retracted toseparate from first or distal frame 102, as shown in FIG. 7, such thatfirst or distal frame 102 does not contact proximal frame 104 and isdecoupled from delivery system 100. In FIG. 7, flat wires 146 are shownradially extending beyond proximal frame 104 for illustrative purposesonly. When in use, elongate tube 136 having flat wires 146longitudinally extending therefrom would be proximally retracted suchthat flat wires 146 were at least partially housed within outer sheathcomponent 106.

More particularly, FIGS. 8-14 illustrate the steps for deploying firstand second frames 102, 104 and decoupling at least first or distal frame102 from delivery system 100. In FIG. 8, outer sheath component 106 isbeing proximally retracted as shown by directional arrow 152 and firstor distal frame 102 is partially deployed. Although hidden from view inthis figure, second or proximal frame 104 is compressed and restrainedwithin outer sheath component 106 and flat wires 146 are woven throughoverlapping openings 156, 166 of first and second frames 102, 104 alongcircumferential overlap region 162 in order to releasably couple firstand second frames 102, 104 together as described with respect to FIG. 6.When outer sheath component 106 is proximally retracted to uncover firstor distal frame 102, flat wires 146 slow the self-expansion of the firstframe to control deployment thereof. Stated another way, the expansionrate of distal frame 102 is slower with flat wires 146 disposedthereover as compared to the expansion rate of distal frame 102 withoutflat wires 146 disposed thereover. Slower expansion results in morecontrolled and predictable deployment of distal frame 102.

Retraction of outer sheath component 106 continues until first or distalframe 102 is completely outside of outer sheath component 106 and thusfully expanded as shown in FIG. 9. In FIG. 9, second or proximal frame104 is partially deployed or expanded with outer sheath component 106still disposed over a proximal portion thereof. At this stage ofdeployment, flat wires 146 are still woven through overlapping openings156, 166 of first and second frames 102, 104 along circumferentialoverlap region 162 in order to releasably couple first and second frames102, 104 together as described with respect to FIG. 6. When outer sheathcomponent 106 is proximally retracted to uncover second or proximalframe 102, flat wires 146 slow the self-expansion of the second frame tocontrol deployment thereof. When each of the first and second frames isat least partially expanded distal of outer sheath component 106 whileremaining coupled to each other by flat wires 146, first and secondframes 102, 104 are recapturable by outer sheath component 106. Moreparticularly, if repositioning of first frame 102 is desired, outersheath component 106 may be distally advanced over flat wires 146 andfirst and second frames 102, 104 in order to recapture first and secondframes 102, 104 within outer sheath component 106. When recaptured,first and second frames 102, 104 resume their compressed, deliveryconfiguration described above with respect to FIG. 5 and first frame 102may be repositioned.

Retraction of outer sheath component 106 continues until both first andsecond frames 102, 104 are completely outside of outer sheath component106 and thus fully expanded as shown in FIG. 10. At this stage ofdeployment, flat wires 146 are still woven through overlapping openings156, 166 of first and second frames 102, 104 along circumferentialoverlap region 162 in order to releasably couple first and second frames102, 104 together as described with respect to FIG. 6, and first andsecond frames 102, 104 are still recapturable by outer sheath component106 as described above.

Once first frame 102 is positioned as desired (i.e., repositioning is nolonger desired and recapturability is thus no longer required), flatwires 146 are proximally retracted in order to decouple first or distalframe 102 from second or proximal frame 104 and delivery system 100 asshown in FIG. 11. More particularly, elongate tube 136 having flat wires146 attached thereto is proximally retracted relative to inner shaft 116until distal ends 150 of flat wires 146 are positioned proximal tosecond or proximal frame 104. Distal ends 150 are preferably rounded andflat wires 146 are sufficiently flexible in order to avoid potentialtissue damage during retraction thereof.

After first or distal frame 102 is decoupled from delivery system 100,second or proximal frame 104 is proximally retracted in order toseparate first and second frames 102, 104. More particularly, innershaft 116 having second frame 104 coupled thereto is proximallyretracted relative to elongate tube 136 until a gap or space 153 spansbetween first and second frames 102, 104 as shown in FIG. 12. Asdescribed above, prior to separation thereof, distal end 170 of secondor proximal frame 104 is disposed within proximal end 158 of first ordistal frame 102. As such, at this stage of deployment, first or distalframe 102 is expanded into apposition with the vessel wall and thusremains in position when second or proximal frame 104 is proximallyretracted and detached therefrom.

After first and second frames 102, 104 are separated from each other,inner shaft 116 is further proximally retracted relative to outer sheathcomponent 106 in order to recapture second or proximal frame 104. Asinner shaft 116 is pulled into outer sheath component 106, if notpreviously retracted into outer sheath component 106, flat wires 146 arealso further proximally retracted relative to outer sheath component 106in order to be recaptured with proximal frame 104. In FIG. 13, second orproximal frame 104 is shown partially recaptured with outer sheathcomponent 106 disposed over a proximal portion thereof. In FIG. 14,second or proximal frame 104 is shown fully recaptured within outersheath component 106. Once fully recaptured, second or proximal frame104 may be removed or may be repositioned for deployment thereof. Moreparticularly, when proximal frame 104 is a permanent component of thedelivery system according to an embodiment hereof as will be describedin more detail herein with respect to FIGS. 15-23, proximal frame 104 isready for removal once it is decoupled from distal frame 102 andrecaptured by outer sheath component 106. In another embodiment hereof,when proximal frame 104 detachable from the delivery system and is not apermanent component of the delivery system as will be described in moredetail herein with respect to FIGS. 24-33, proximal frame 104 is readyto be positioned for deployment thereof once it is decoupled from distalframe 102 and recaptured by outer sheath component 106. Althoughrecapture of second or proximal frame 104 is described via proximalretraction of inner shaft 116, it would be understood by those ofordinary skill in the art that the required relative movement betweenouter sheath component 106 and inner shaft 116 may be accomplished viadistal advancement of outer sheath component 106.

FIGS. 15-23 illustrate an embodiment hereof in which the first or distalframe is the scaffold of a valve prosthesis that is delivered bydelivery system 100 and the second or proximal frame is a permanentcomponent of delivery system 100. Flat wires 146 and the proximal framecouple the valve prosthesis to delivery system 100 and flat wires 146are utilized in deployment of the valve prosthesis. In this embodiment,a first or distal frame 1602 is the scaffold of a valve prosthesis, andthus first or distal frame 1602 may be referred to herein as valve frame1602 and a second or proximal frame 1504 may be referred to herein asdelivery frame 1504.

FIG. 15 illustrates a distal portion of a distal portion of inner shaft116 having delivery frame 1504 attached thereto, with inner shaft 116and delivery frame 1504 removed from the remainder of the deliverysystem for illustrative purposes only. In this embodiment hereof, distalend 122 of inner shaft 116 is permanently attached or secured to aproximal end of delivery frame 1504 to be slidable therewith. Distal end122 of inner shaft 116 may be permanently attached or secured to aproximal end of delivery frame 1504 via welding, use or more one oradhesives, bonding, or via other mechanical methods known in the art.Delivery frame 1504 is shown in its expanded or deployed configuration.FIG. 16 illustrates valve frame 1602 in its expanded or deployedconfiguration, removed from the delivery system for illustrativepurposes only. Similar to first and second frames 102, 104 describedabove, valve and delivery frames 1602, 1504 each include aself-expanding scaffold 1654, 1564, respectively, that returns to anexpanded deployed state from a compressed or constricted delivery state.In this embodiment, self-expanding scaffolds 1654, 1564 are tubularcomponents having proximal ends or segments 1658, 1568, respectively,and distal ends or segments 1660, 1570, respectively, withdiamond-shaped openings 1656, 1566, respectively, that may be formed bya laser-cut manufacturing method and/or another conventionalstent/scaffold forming method as would be understood by one of ordinaryskill in the art.

In this embodiment, valve frame 1602 includes a prosthetic valvecomponent 1673 disposed within and secured to scaffold 1654. Prostheticvalve component 1673 includes at least two valve leaflets 1674 disposedwithin and secured to scaffold 1654. Prosthetic valve component 1673 iscapable of blocking flow in one direction to regulate flow there-throughvia valve leaflets 1674 that may form a bicuspid or tricuspidreplacement valve. FIG. 17 is an end view of prosthetic valve component1673 taken from the second or outflow end thereof. FIG. 17 illustratesan exemplary tricuspid valve having three leaflets 1674, although abicuspid leaflet configuration may alternatively be used in embodimentshereof. More particularly, if prosthetic valve component 1673 isconfigured for placement within a native valve having three leafletssuch as the aortic, tricuspid, or pulmonary valves, prosthetic valvecomponent 1673 includes three valve leaflets 1674 although the valveprosthesis is not required to have the same number of leaflets as thenative valve. If prosthetic valve component 1673 is configured forplacement within a native valve having two leaflets such as the mitralvalve, prosthetic valve component 1673 includes two or three valveleaflets 1674. Valve leaflets 1674 are sutured or otherwise securely andsealingly attached (i.e., via suitable biocompatible adhesive) to theinner surface of scaffold 1654. Adjoining pairs of leaflets are attachedto one another at their lateral ends to form commissures 1676, with freeedges 1678 of the leaflets forming coaptation edges that meet in area ofcoaptation 1680. Valve frame 1602 and prosthetic valve component 1673may be collectively referred to herein as a valve prosthesis 1675.

Leaflets 1674 may be made of pericardial material; however, the leafletsmay instead be made of another material. Natural tissue for replacementvalve leaflets may be obtained from, for example, heart valves, aorticroots, aortic walls, aortic leaflets, pericardial tissue, such aspericardial patches, bypass grafts, blood vessels, intestinal submucosaltissue, umbilical tissue and the like from humans or animals. Syntheticmaterials suitable for use as leaflets 1674 include DACRON® commerciallyavailable from Invista North America S.A.R.L. of Wilmington, Del., othercloth materials, nylon blends, and polymeric materials. One polymericmaterial from which the leaflets can be made is an ultra-high molecularweight polyethylene material commercially available under the tradedesignation DYNEEMA from Royal DSM of the Netherlands. With certainleaflet materials, it may be desirable to coat one or both sides of theleaflet with a material that will prevent or minimize overgrowth. It isfurther desirable that the leaflet material is durable and not subjectto stretching, deforming, or fatigue.

Valve frame 1602 may also include a tubular body or graft material 1672attached to an inner or outer surface of scaffold 1654. It will beunderstood by one of ordinary skill in the art that at least someportions of scaffold 1654 are not covered by the graft material suchthat flat wires 146 may be woven or passed therethrough. Graft material1672 may be formed from any suitable biocompatible material, for exampleand not limited to, a low-porosity woven or knit polyester, DACRON®,polytetrafluoroethylene (PTFE), polyurethane, silicone, or othersuitable materials. Graft material 1672 is thin-walled so that valveframe 1602 may be compressed into a small diameter, yet is capable ofacting as a strong, leak-resistant fluid conduit when expanded to acylindrical tubular form. In one embodiment, graft material 1672 may bea knit or woven polyester, such as a polyester or PTFE knit, which canbe utilized when it is desired to provide a medium for tissue ingrowthand the ability for the fabric to stretch to conform to a curvedsurface. Polyester velour fabrics may alternatively be used, such aswhen it is desired to provide a medium for tissue ingrowth on one sideand a smooth surface on the other side. These and other appropriatecardiovascular fabrics are commercially available from Bard PeripheralVascular, Inc. of Tempe, Ariz., for example. In another embodiment, thegraft material could also be a natural material such as pericardium oranother membranous tissue such as intestinal submucosa.

It will be understood by one of ordinary skill in the art that theillustrated configuration of scaffold 1654 is exemplary and scaffold1654 may have an alternative pattern or configuration. For example, inanother embodiment shown in FIG. 18, a scaffold 1854 of a valve frame1802 is shown. Scaffold 1854 is configured to easily recapture intodelivery system 100 and controlled release thereof is improved due tothe relatively smaller amount of material at the outflow end thereof.More particularly, scaffold 1854 includes an outflow end 1826, an inflowend 1828, and an intermediate portion 1830 extending therebetween.Openings 1834 of intermediate portion 1830 are relatively larger in sizethan openings 1835 of inflow end 1828. Outflow end 1826 includes threecircumferentially spaced-apart extensions 1832 that are bulged or flaredcompared to intermediate portion 1830 and inflow end 1828. Outflow end1826 thus has a relatively smaller amount of scaffold material comparedto the amount of scaffold material at inflow end 1828. Due to theconfiguration of outflow end 1832, valve frame 1802 is relatively easierto recapture via outer sheath component 106 of delivery system 100. Asshown in FIG. 18, outflow end 1826 has a diameter D₂ which is largerthan a diameter D₁ of opposing inflow end 1828. The sizes of diametersD₁ and D₂ may vary according to a particular patient's anatomy and/orthe intended native valve for replacement.

FIGS. 19-23 illustrate an exemplary method of implanting theabove-described valve frame 1602 within a native valve according to anembodiment hereof. As described above with respect to FIG. 5, when inthe compressed delivery configuration, valve and delivery frames 1602,1504 are mounted in series with the proximal end of distal or valveframe 1602 overlapping the distal end of proximal or delivery frame 1504at an overlap region. Valve and delivery frames 1602, 1504 are held in aradially compressed configuration via outer sheath component 106. Theradially compressed configurations of valve and delivery frames 1602,1504 are suitable for percutaneous delivery within a vasculature. Asshown in FIG. 19, in accordance with techniques known in the field ofinterventional cardiology and/or interventional radiology, deliverysystem 100 having a plunger 1992 disposed there-through istransluminally advanced in a retrograde approach over a guidewire 1996through the vasculature to the treatment site, which in this instance isa target diseased native aortic valve AV that extends between apatient's left ventricle LV and a patient's aorta A. The coronaryarteries C_(A) are also shown on the sectional view of FIG. 19. Plunger1992 includes a dilator tip 1994 at a distal end thereof. Delivery ofdelivery system 100 to the native aortic valve AV may be accomplishedvia a percutaneous transfemoral approach or may be positioned within thedesired area of the heart via different delivery methods known in theart for accessing heart valves. During delivery, i.e., while beingtracked over guidewire 1996, valve and delivery frames 1602, 1504 remaincompressed within outer sheath component 106 of delivery system 100.Delivery system 100 is advanced until distal end 112 of outer sheathcomponent 106 is distal to the native aortic valve AV and disposedwithin the left ventricle LV as shown in FIG. 19. In an embodiment,delivery system 100 is advanced approximately 5 mm into the leftventricle LV.

Once delivery system 100 is positioned as desired, outer sheathcomponent 106 is proximally retracted in order to radially expand ordeploy valve and delivery frames 1602, 1504 as shown in FIG. 20. At thisstage of deployment, flat wires 146 are woven through overlappingopenings 1656, 1566 of valve and delivery frames 1602, 1504 along acircumferential overlap region 2062 in order to releasably couple valveand delivery frames 1602, 1504 together as described with respect toFIG. 6. The graft material of valve frame 1602 is not shown in FIGS.20-23 for sake of clarity. When outer sheath component 106 is proximallyretracted to uncover valve and delivery frames 1602, 1504, flat wires146 slow the self-expansion of valve and delivery frames 1602, 1504 tocontrol deployment thereof. When valve frame 1602 is at least partiallyexpanded distal of outer sheath component 106 while remaining coupled todelivery frame 1504 by flat wires 146, valve prosthesis 1675 isrecapturable by outer sheath component 106 being distally advanced overflat wires 146. More particularly, if repositioning of valve frame 1602is desired, outer sheath component 106 may be distally advanced overflat wires 146 in order to recapture valve and delivery frames 1602,1504 within outer sheath component 106. When recaptured, valve anddelivery frames 1602, 1504 resume their compressed, deliveryconfiguration described above with respect to FIG. 5 and valve frame1602 may be repositioned.

Once valve prosthesis 1675 is positioned as desired (i.e., repositioningis no longer desired and recapturability is thus no longer required),flat wires 146 are proximally retracted in order to decouple valve frame1602 from delivery frame 1504 and delivery system 100 as shown in FIG.21. More particularly, elongate tube 136 having flat wires 146 attachedthereto is proximally retracted relative to inner shaft 116 until distalends 150 of flat wires 146 are positioned proximal to delivery frame1504. Proximal retraction of flat wires 146 from valve frame 1602releases valve prosthesis 1675 from delivery system 100.

After valve prosthesis 1675 is decoupled from delivery system 100,delivery frame 1504 is proximally retracted in order to separate valveand delivery frames 1602, 1504. More particularly, inner shaft 116having delivery frame 1504 attached thereto is proximally retractedrelative to elongate tube 136 until a gap or space 2253 spans betweenvalve and delivery frames 1602, 1504 as shown in FIG. 22. As describedabove, prior to separation thereof, the distal end of delivery frame1504 is disposed within the proximal end of valve frame 1602. As such,at this stage of deployment, valve frame 1602 is expanded intoapposition with the native heart valve, and thus remains in positionwhen delivery frame 1504 is proximally retracted and detached therefrom.

After valve and delivery frames 1602, 1504 are separated from eachother, inner shaft 116 is further proximally retracted relative to outersheath component 106 in order to recapture delivery frame 1504 as shownin FIG. 23. As inner shaft 116 is pulled into outer sheath component106, if not previously retracted into outer sheath component 106, flatwires 146 are also further proximally retracted relative to outer sheathcomponent 106 in order to be recaptured with proximal frame 104. In FIG.23, delivery frame 1504 is shown partially recaptured with outer sheathcomponent 106 disposed over a proximal portion thereof. Once deliveryframe 1504 is fully recaptured within outer sheath component 106,delivery system 100 including delivery frame 1504 attached thereto maybe removed.

Advantageously, valve frame 1602 may be a relatively short valve framethat does not block or extend over the coronary arteries C_(A) as shownin FIGS. 20-23. In an embodiment, valve frame 1602 has a length of 35 mmor less. Delivery frame 1504 permits the relatively short valve frame1602 to be deployed similar to a longer frame via the use of flat wires146 that attach valve frame 1602 to delivery system 100. Moreparticularly, during the deployment of a self-expanding frame from anouter sheath, the radial force of the frame as it is partially deployedcreates a force in the distal direction. When a relatively short frameis released, the frame may move in the direction of the outer sheathretraction and may cant at the implantation site, which is unintentionalslanting or tilting of the frame. If a valve prosthesis is notcircumferentially centered relative to the native annulus, the deployedvalve prosthesis may dislodge from the implantation site and/orundesirable paravalvular leakage and/or regurgitation may occur. Thus,it is important that the valve prosthesis be accurately located relativeto the native annulus prior to full deployment of the prosthesis. Withrelatively longer frames, canting is mitigated by the fact that much ofthe frame gradually deploys into contact with tissue at the implantationsite which provides anchoring and control during deployment before thelonger frame is fully released from the outer sheath. Since deliveryframe 1504 and valve frame 1602 are deployed while coupled together,delivery frame 1504 and valve frame 1602 collectively deploy similar toa longer frame and thus reduce the chance of valve frame 1602 canting.Delivery frame 1504 and flat wires 146 enable the short valve frame 1602to be gradually released or deployed, and valve frame 1602 remainscoupled to delivery system 100 during deployment thereof so that valveframe 1602 deploys into contact with tissue at the implantation siteprior to release from the delivery system.

FIGS. 24-33 illustrate an embodiment hereof in which the first or distalframe is a docking frame that is configured to receive the second orproximal frame having a prosthetic valve component secured therein.Thus, in this embodiment, the second or proximal frame is not apermanent component of delivery system 100 but rather distal end 122 ofinner shaft 116 is releasably coupled to the proximal end of the secondor proximal frame such that the proximal frame may be selectivelydetached from the delivery system. In this embodiment, a second orproximal frame 2404 is the scaffold of a valve prosthesis, and thussecond or proximal frame 2404 may be referred to herein as valve frame2404 and a first or distal frame 2602 may be referred to herein asdocking frame 2602. Flat wires 146 of delivery system 100 couple dockingand valve frames 2602, 2404 together and are utilized in deployment ofboth of the frames as will be described in more detail herein. Deliverysystem 100 thus is utilized for a two-stage deployment in which dockingframe 2602 and valve frame 2404 are concurrently delivered or advancedto the target native valve or treatment site but docking frame 2602 isdeployed prior to valve frame 2404. Docking frame 2602 is configured tobe released from and implanted by delivery system 100 at an implantationsite, i.e., within one of a native heart valve or previously implantedprosthetic valve, and thereafter valve frame 2404 with the prostheticvalve component secured therein is configured to be released from andimplanted by delivery system 100 within docking frame 2602.

More particularly, FIG. 24 illustrates a distal portion of inner shaft116 having valve frame 2404 attached thereto, with inner shaft 116 andvalve frame 2404 removed from the remainder of the delivery system forillustrative purposes only. In this embodiment hereof, distal end 122 ofinner shaft 116 is releasably attached or secured to a proximal end ofvalve frame 2404 to be slidable therewith. More particularly, withreference to FIG. 25, distal end 122 of inner shaft 116 includes adistal hub 2582 which functions to releasably couple the proximal end ofvalve frame 2404 to inner shaft 116. Distal hub 2582 includes recesses2584 while the proximal end of valve frame 2404 includes paddles 2586proximally extending from the proximal end of the valve frame. Paddles2586 are configured to mate or be received within recesses 2584 ofdistal hub 2582 to couple valve frame 2404 to inner shaft 116. However,when it is desired to deploy valve frame 2404 as described herein,self-expansion of valve frame 2404 causes paddles 2586 to release orexit out of recesses 2584, thereby decoupling valve frame 2404 frominner shaft 116. As shown in FIG. 25, distal hub 2582 may also includelongitudinal grooves 2588 configured to allow passage and sliding offlat wires 146 longitudinally extending from elongate tube 136thereover. In the embodiment of FIG. 25, distal end 142 of elongate tube136 includes a distal hub 2590 for attachment or securement of flatwires 146 to elongate tube 136. Flat wires 146 may be glued, welded,molded, or otherwise mechanically attached to distal hub 2590, anddistal hub 2590 similarly may be glued, welded, molded, or otherwisemechanically attached to distal end 142 of elongate tube 136. Althoughnot shown, it will be understood by one of ordinary skill in the artthat a distal hub similar to distal hub 2590 may be incorporated intoany embodiment described herein for attaching flat wires 146 to distalend 142 of elongate tube 136.

Valve frame 2404 is shown in its expanded or deployed configuration inFIG. 24, and docking frame 2602 is shown in its expanded or deployedconfiguration in FIG. 26, removed from the delivery system forillustrative purposes only. Similar to first and second frames 102, 104described above, docking and valve frames 2602, 2404 each include aself-expanding scaffold 2654, 2464, respectively, that returns to anexpanded deployed state from a compressed or constricted delivery state.In this embodiment, self-expanding scaffolds 2654, 2464 are tubularcomponents having proximal ends or segments 2658, 2468, respectively,and distal ends or segments 2660, 2470, respectively, withdiamond-shaped openings 2656, 2466, respectively, that may be formed bya laser-cut manufacturing method and/or another conventionalstent/scaffold forming method as would be understood by one of ordinaryskill in the art. In this embodiment, docking and valve frames 2602,2404 each include a tubular body or graft material 2672, 2472,respectively, attached to an inner or outer surface of scaffold 2654,2464, respectively. Graft material 2672, 2472 may be formed from anysuitable biocompatible material, for example and not limited to, alow-porosity woven or knit polyester, DACRON®, polytetrafluoroethylene(PTFE), polyurethane, silicone, or other suitable materials describedabove with respect to graft material 1672.

In this embodiment, valve frame 2404 includes a prosthetic valvecomponent 2473 disposed within and secured to scaffold 2464. Prostheticvalve component 2473 is the same as prosthetic valve component 1673described above, and includes at least two valve leaflets 2474 disposedwithin and secured to scaffold 2464. Valve frame 2404 and prostheticvalve component 2473 may be collectively referred to herein as a valveprosthesis 2475. Docking frame 2602 is sized or configured to receivevalve prosthesis 2475. More particularly, docking frame 2602 isconfigured to fit and conform to the anatomy when expanded or deployedin situ in order to prevent paravalvular leakage (PVL) and valveprosthesis 2475 is implanted into docking frame 2602. As such, dockingframe 2602 may be designed, sized, or otherwise configured to fit andconform to native heart anatomy at any desired valve location (i.e.,aortic, mitral, tricuspid, pulmonic).

FIGS. 27-33 illustrate an exemplary method of implanting theabove-described docking frame 2602 and valve frame 2404 within a nativevalve according to an embodiment hereof. As described above with respectto FIG. 5, when in the compressed delivery configuration, docking andvalve frames 2602, 2404 are mounted in series with the proximal end ofdistal or docking frame 2602 overlapping the distal end of proximal orvalve frame 2404 at an overlap region. Docking and valve frames 2602,2404 are held in a radially compressed configuration via outer sheathcomponent 106. The radially compressed configurations of docking andvalve frames 2602, 2404 are suitable for percutaneous delivery within avasculature. As shown in FIG. 27, in accordance with techniques known inthe field of interventional cardiology and/or interventional radiology,delivery system 100 having a plunger 1992 disposed there-through istransluminally advanced in a retrograde approach over a guidewire 1996through the vasculature to the treatment site, which in this instance isa target diseased native aortic valve AV that extends between apatient's left ventricle LV and a patient's aorta A. The coronaryarteries C_(A) are also shown on the sectional view of FIG. 27. Plunger1992 includes a dilator tip 1994 at a distal end thereof. Delivery ofdelivery system 100 to the native aortic valve AV may be accomplishedvia a percutaneous transfemoral approach or may be positioned within thedesired area of the heart via different delivery methods known in theart for accessing heart valves. During delivery, i.e., while beingtracked over guidewire 1996, docking and valve frames 2602, 2404 remaincompressed within an outer sheath component 106 of delivery system 100.Delivery system 100 is advanced until distal end 112 of outer sheathcomponent 106 is distal to the native aortic valve AV and disposedwithin the left ventricle LV as shown in FIG. 27. In an embodiment,delivery system 100 is advanced approximately 5 mm into the leftventricle LV.

Once delivery system 100 is positioned as desired, outer sheathcomponent 106 is proximally retracted in order to radially expand ordeploy docking and valve frames 2602, 2404 as shown in FIG. 28. At thisstage of deployment, flat wires 146 are woven through overlappingopenings 2656, 2466 of docking and valve frames 2602, 2404 along acircumferential overlap region 2862 in order to releasably coupledocking and valve frames 2602, 2404 together as described with respectto FIG. 6. The graft material of docking and valve frames 2602, 2404 isnot shown in FIGS. 28-33 for sake of clarity. When outer sheathcomponent 106 is proximally retracted to uncover docking and valveframes 2602, 2404, flat wires 146 slow the self-expansion of docking andvalve frames 2602, 2404 to control deployment thereof. When dockingframe 2602 is at least partially expanded distal of outer sheathcomponent 106 while remaining coupled to valve frame 2404 by flat wires146, docking frame 2602 is recapturable by outer sheath component 106being distally advanced over flat wires 146. More particularly, ifrepositioning of docking frame 2602 is desired, outer sheath component106 may be distally advanced over flat wires 146 in order to recapturedocking and valve frames 2602, 2404 within outer sheath component 106.When recaptured, docking and valve frames 2602, 2404 resume theircompressed, delivery configuration described above with respect to FIG.5 and docking frame 2602 may be repositioned.

Once docking frame 2602 is positioned as desired (i.e., repositioning isno longer desired and recapturability is thus no longer required), flatwires 146 are proximally retracted in order to decouple docking frame2602 from valve prosthesis 2475 and delivery system 100 as shown in FIG.29. More particularly, elongate tube 136 having flat wires 146 attachedthereto is proximally retracted relative to inner shaft 116 until distalends 150 of flat wires 146 are positioned proximal to valve prosthesis2475. Proximal retraction of flat wires 146 from docking frame 2602releases docking frame 2602 from delivery system 100.

After docking frame 2602 is decoupled from delivery system 100, valveframe 2404 is proximally retracted in order to separate docking andvalve frames 2602, 2404. More particularly, as described above withrespect to FIG. 25, valve frame 2404 is releasably coupled to innershaft 116 to be slideable therewith at this stage of deployment. Paddles2586 (shown on FIG. 25) of valve frame 2404 are configured to mate or bereceived within recesses 2584 of distal hub 2582 to couple valve frame2404 to inner shaft 116. In order to proximally retract valve frame2404, inner shaft 116 having valve frame 2404 coupled thereto isproximally retracted relative to elongate tube 136 until a gap or space3053 spans between docking and valve frames 2602, 2404 as shown in FIG.30. As described above, prior to separation thereof, the distal end ofvalve frame 2404 is disposed within the proximal end of docking frame2602. As such, at this stage of deployment, docking frame 2602 isexpanded into apposition with the native valve and thus remains inposition when valve frame 2404 is proximally retracted and detachedtherefrom.

After docking and valve frames 2602, 2404 are separated from each other,inner shaft 116 is further proximally retracted relative to outer sheathcomponent 106 in order to recapture valve frame 2404 as shown in FIG.31. Valve prosthesis 2475 is still releasably coupled to inner shaft 116at this stage of deployment such that valve prosthesis 2475 is slideablewith inner shaft 116. As inner shaft 116 is pulled into outer sheathcomponent 106, if not previously retracted into outer sheath component106, flat wires 146 are also further proximally retracted relative toouter sheath component 106 in order to be recaptured with valve frame2404. In FIG. 31, valve prosthesis 2475 is shown fully recaptured withouter sheath component 106. Once valve prosthesis 2475 is fullyrecaptured within outer sheath component 106, valve prosthesis 2475 isready to be positioned for deployment thereof. Thus, in FIG. 32,delivery system 100 (with outer sheath component 106 having valveprosthesis 2475 radially compressed therein) is distally advanced toposition valve prosthesis 2475 within deployed docking frame 2602. Whenvalve prosthesis 2475 is positioned as desired, i.e., is longitudinallyaligned and concentrically aligned within docking frame 2602, outersheath component 106 is proximally retracted in order to radially expandor deploy valve frame 2404 into apposition with docking frame 2602 asshown in FIG. 33. As described above with respect to FIG. 25, when valveprosthesis 2475 is released from outer sheath component 106 fordeployment, self-expansion of valve frame 2404 causes paddles 2586 torelease or exit out of recesses 2584 to decouple valve prosthesis 2475from inner shaft 116.

While various embodiments according to the present invention have beendescribed above, it should be understood that they have been presentedby way of illustration and example only, and not limitation. It will beapparent to persons skilled in the relevant art that various changes inform and detail can be made therein without departing from the spiritand scope of the invention. Thus, the breadth and scope of the presentinvention should not be limited by any of the above-described exemplaryembodiments, but should be defined only in accordance with the appendedclaims and their equivalents. It will also be understood that eachfeature of each embodiment discussed herein, and of each reference citedherein, can be used in combination with the features of any otherembodiment. All patents and publications discussed herein areincorporated by reference herein in their entirety.

1-20. (canceled)
 21. A method of implanting a valve prosthesis within anative valve, the method comprising the steps of: percutaneouslyadvancing a delivery system to the native valve, wherein the deliverysystem includes an outer sheath component defining a lumen therethrough,an elongate tube defining a lumen and having at least two wireslongitudinally extending from a distal end thereof, and an inner shaftslidably disposed within the lumen of the elongate tube, the elongatetube and the at least two wires being slidably disposed within the lumenof the outer sheath component, and wherein the delivery system furtherincludes a self-expanding delivery frame having a proximal end attachedto the inner shaft to be slidable therewith and a valve prosthesishaving a self-expanding valve frame with a prosthetic valve componentsecured therein, the valve frame being disposed distal of the deliveryframe and each frame being held in a compressed delivery configurationwithin a distal portion of the outer sheath component, wherein the atleast two wires longitudinally extend along exterior portions of thedelivery frame and the valve frame and are woven through adjacent distaland proximal ends of the delivery frame and the valve frame,respectively, to releasably couple them to each other; proximallyretracting the outer sheath component to uncover the valve frame andthereby deploy the valve frame to an expanded configuration within thenative valve; further proximally retracting the outer sheath componentto uncover the delivery frame and thereby deploy the delivery frame toan expanded configuration; and proximally retracting the at least twowires from the deployed valve frame to uncouple the deployed valve framefrom the deployed delivery frame.
 22. The method of claim 21, furthercomprising the step of proximally retracting the inner shaft torecapture the delivery frame within the outer sheath component forremoval thereof after implantation of the valve prosthesis.
 23. Themethod of claim 21, wherein when in the compressed deliveryconfiguration a distal segment of the delivery frame is nested within aproximal segment of the valve frame to provide a circumferential overlaptherebetween and in the circumferential overlap each of the at least twowires is woven through a respective distalmost crown of the deliveryframe to releasably couple the delivery frame and the valve frame toeach other.
 24. The method of claim 21, wherein when the outer sheathcomponent is proximally retracted to uncover the valve frame the atleast two wires slow the self-expansion of the valve frame to controldeployment of the valve prosthesis.
 25. The method of claim 21, whereinwhen the outer sheath component is further proximally retracted touncover the delivery frame the at least two wires slow theself-expansion of the delivery frame.
 26. The method of claim 21,further comprising the step of distally advancing the outer sheathcomponent over the at least two wires in order to recapture the valveprosthesis when the valve frame is at least partially expanded distal ofthe outer sheath component while remaining coupled to the delivery frameby the at least two wires.
 27. The method of claim 21, wherein the atleast two wires are flat and proximal retraction of the at least twoflat wires from the deployed valve frame releases the deployed valveprosthesis from the delivery system.
 28. A method of implanting a firstframe and a second frame at a treatment site in situ, the methodcomprising the steps of: percutaneously advancing a delivery system tothe treatment site, wherein the delivery system includes an outer sheathcomponent defining a lumen therethrough, an elongate tube defining alumen and having at least two wires longitudinally extending from adistal end thereof, and an inner shaft slidably disposed within thelumen of the elongate tube, the elongate tube and the at least two wiresbeing slidably disposed within the lumen of the outer sheath component,and wherein the delivery system further includes a first frame that isself-expanding and a second frame that is self-expanding, each framebeing held in a compressed delivery configuration within a distalportion of the outer sheath component and the first frame being disposeddistal of the second frame, and wherein the at least two wireslongitudinally extend along exterior portions of each of the first frameand the second frame and are woven through adjacent ends of each of thefirst frame and the second frame to releasably couple them to eachother; proximally retracting the outer sheath component to uncover thefirst frame and thereby deploy the first frame to an expandedconfiguration at the treatment site; further proximally retracting theouter sheath component to uncover the second frame and thereby deploythe second frame to an expanded configuration; and proximally retractingthe at least two wires from the deployed first frame to uncouple thedeployed first frame from the deployed second frame.
 29. The method ofclaim 28, wherein second frame has a proximal end attached to the innershaft to be slidable therewith.
 30. The method of claim 29, wherein thefirst frame includes a prosthetic valve component secured therein. 31.The method of claim 29, further comprising the step of proximallyretracting the inner shaft to recapture the second frame within theouter sheath component for removal thereof after the step of proximallyretracting the at least two wires from the deployed first frame touncouple the deployed first frame from the deployed second frame. 32.The method of claim 28, wherein when in the compressed deliveryconfiguration a distal segment of the second frame is nested within aproximal segment of the first frame to provide a circumferential overlaptherebetween and in the circumferential overlap each of the at least twowires is woven through a respective distalmost crown of the second frameto releasably couple the second frame and the first frame to each other.33. The method of claim 28, wherein when the outer sheath component isproximally retracted to uncover the first frame the at least two wiresslow the self-expansion of the first frame.
 34. The method of claim 28,wherein when the outer sheath component is further proximally retractedto uncover the second frame the at least two wires slow theself-expansion of the second frame.
 35. The method of claim 28, furthercomprising the step of distally advancing the outer sheath componentover the at least two wires in order to recapture the first frame whenthe first frame is at least partially expanded distal of the outersheath component while remaining coupled to the second frame by the atleast two wires.
 36. The method of claim 28, wherein the at least twowires are flat.
 37. The method of claim 28, wherein the second frame isreleasably coupled to a distal end of the inner shaft to be slidabletherewith relative to the elongate tube.
 38. The method of claim 37,further comprising the steps of: recapturing the deployed second frameinto the outer sheath component; repositioning the recaptured secondframe within the deployed first frame; and proximally retracting theouter sheath component to uncover the recaptured second frame andthereby deploy the second frame to an expanded configuration within thedeployed first frame.
 39. The method of claim 38, further comprising thestep of proximally retracting the at least two wires from the deployedsecond frame to uncouple the deployed second frame from the deliverysystem.
 40. The method of claim 38, wherein the second frame includes aprosthetic valve component secured therein.